NCT04941534

Brief Summary

This clinical study will evaluate the safety and comparative performance of Biorithm Research Kit vs CTG (gold standard) in prenatal monitoring of pregnant participants.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 4, 2021

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

June 22, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 28, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2022

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

1 year

First QC Date

June 22, 2021

Last Update Submit

February 7, 2023

Conditions

Pregnancy

Keywords

antepartum monitoring

Outcome Measures

Primary Outcomes (2)

  • Fetal Heart Rate (FHR)

    FHR agreement between Biorithm Research Kit and standard of care (CTG)

    60 minutes

  • Maternal Heart Rate (MHR)

    MHR agreement between Biorithm Research Kit and standard of care (CTG)

    60 minutes

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Participants would be recruited at the Day Assessment Unit who require CTG monitoring and meet the inclusion criteria

You may qualify if:

  • Have a singleton pregnancy
  • Should be at and above 28 weeks of pregnancy
  • Should have a valid indication for antenatal FHR monitoring as part of their pregnancy management, as per local hospital policy
  • Able to speak English or have access to an interpreter and provide Informed Consent

You may not qualify if:

  • Participants with an intellectual or mental impairment
  • Participants with a known allergy or hypersensitivity to ECG gel electrodes
  • Participants in pain, with contractions or in labour
  • Known fetal cardiac or genetic abnormality
  • Participant with a pacemaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St George's University Hospital

London, SW17ORE, United Kingdom

Location

Related Publications (2)

  • Liu B, Marler E, Thilaganathan B, Bhide A. Ambulatory antenatal fetal electrocardiography in high-risk pregnancies (AMBER): protocol for a pilot prospective cohort study. BMJ Open. 2023 Apr 13;13(4):e062448. doi: 10.1136/bmjopen-2022-062448.

    PMID: 37055213DERIVED

  • Liu B, Thilaganathan B, Bhide A. Effectiveness of ambulatory non-invasive fetal electrocardiography: impact of maternal and fetal characteristics. Acta Obstet Gynecol Scand. 2023 May;102(5):577-584. doi: 10.1111/aogs.14543. Epub 2023 Mar 21.

    PMID: 36944583DERIVED

Study Officials

  • Baskaran Thilaganathan

    St-George's University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2021

First Posted

June 28, 2021

Study Start

June 4, 2021

Primary Completion

June 22, 2022

Study Completion

July 30, 2022

Last Updated

February 8, 2023

Record last verified: 2023-02

Locations

GB(1)